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Last Updated: April 26, 2024

CLINICAL TRIALS PROFILE FOR TELAPREVIR

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505(b)(2) Clinical Trials for Telaprevir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01511432 ↗	A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects	Completed	Vertex Pharmaceuticals Incorporated	Phase 1	2012-01-01	The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
>Trial Type	>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

All Clinical Trials for Telaprevir

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00336479 ↗	Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C	Completed	Vertex Pharmaceuticals Incorporated	Phase 2	2006-06-01	Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
NCT00372385 ↗	Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C	Completed	Vertex Pharmaceuticals Incorporated	Phase 2	2006-08-01	Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
NCT00420784 ↗	A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)	Completed	Vertex Pharmaceuticals Incorporated	Phase 2	2007-02-01	The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for Telaprevir

Condition Name

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Condition Name for Telaprevir
Intervention	Trials
Hepatitis C	46
Hepatitis C, Chronic	16
Chronic Hepatitis C	10
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Condition MeSH

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Condition MeSH for Telaprevir
Intervention	Trials
Hepatitis C	89
Hepatitis	78
Hepatitis A	58
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Clinical Trial Locations for Telaprevir

Trials by Country

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Trials by Country for Telaprevir
Location	Trials
United States	451
Canada	45
Japan	42
Germany	26
Spain	21
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Trials by US State

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Trials by US State for Telaprevir
Location	Trials
Texas	30
New York	26
California	26
Maryland	25
Florida	24
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Clinical Trial Progress for Telaprevir

Clinical Trial Phase

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Clinical Trial Phase for Telaprevir
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	25
Phase 2/Phase 3	2
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Clinical Trial Status

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Clinical Trial Status for Telaprevir
Clinical Trial Phase	Trials
Completed	81
Terminated	11
Unknown status	5
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Clinical Trial Sponsors for Telaprevir

Sponsor Name

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Sponsor Name for Telaprevir
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	36
Tibotec BVBA	12
Tibotec Pharmaceutical Limited	6
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Sponsor Type

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Sponsor Type for Telaprevir
Sponsor	Trials
Industry	106
Other	94
NIH	7
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